A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del (VX18-445-109)

Details

Therapeutic approach
Restore CFTR Function
Trial status
Closed with results Participating Centres
Trials Tracker ID
TT002046
Last updated
08/11/2019
Full title

A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/ Tezacaftor / Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

Study details

A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del

Phase
Phase 3b
Recruitment target
158
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age range
12 years and older
Including people

12 Years and older
Homozygous for the F508del mutation
FEV1 value ≥40% and ≤90%

Excluding people

Clinically significant cirrhosis with or without portal hypertension.
Lung infection

Get in touch

Your donation will make a difference:

CF centres running this trial

Closed

Belfast City Hospital (Adults)

CTAP centre
NHS Trust
Belfast Health & Social Care Trust
Address
Lisburn Road
BT9 7AB
Recruitment starts
Recruitment ends
Local site investigator
Damian Downey
Trial Coordinators
Catherine McNeill
[email protected]
Closed

Birmingham Heartlands Hospital (Adults)

CTAP centre
NHS Trust
University Hospitals Birmingham NHS Foundation Trust
Address
Bordesley Green
B9 5SS
Recruitment starts
Recruitment ends
Local site investigator
Edward Nash
Trial Coordinators
Aoife Neal
[email protected]
Closed

Bristol Royal Hospital for Children

CTAP centre
NHS Trust
University Hospitals Bristol NHS Foundation Trust
Address
Upper Maudlin Street
BS2 8BJ
Recruitment starts
Recruitment ends
Local site investigator
Tom Hilliard
Trial Coordinators
Kate Alderton
[email protected]
Closed

Bristol Royal Infirmary (Adults)

CTAP centre
NHS Trust
University Hospitals Bristol NHS Foundation Trust
Address
Marlborough Street
BS2 8HW
Recruitment starts
Recruitment ends
Local site investigator
Tom Hilliard
Trial Coordinators
Sally Coplowe
[email protected]
Closed

Cambridge Royal Papworth Hospital (Adults)

CTAP centre
NHS Trust
Royal Papworth Hospital NHS Foundation Trust
Address
Papworth Road
CB2 0AY
Recruitment starts
Recruitment ends
Local site investigator
Charles Haworth
Trial Coordinators
Deepa George
[email protected]
Victoria Christenssen
[email protected]
Closed

Glasgow - Queen Elizabeth University Hospital

CTAP centre
NHS Trust
NHS Greater Glasgow & Clyde
Address
1345 Govan Road
G51 4TF
Recruitment starts
Recruitment ends
Local site investigator
Gordon MacGregor
Trial Coordinators
Annie Husband
[email protected]
Closed

Great Ormond Street Hospital for Children (London)

CTAP centre
NHS Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
Address
Great Ormond Street
WC1N 3JH
Recruitment starts
Recruitment ends
Local site investigator
Katharine Pike
Trial Coordinators
Lucy Holt
[email protected]
Closed

King's College Hospital (London)

CTAP centre
NHS Trust
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
SE5 9RS
Recruitment starts
Recruitment ends
Local site investigator
Patricia Macedo
Trial Coordinators
Mélanie Le Sayec
[email protected]
Closed

Leeds Children's Hospital

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
Clarendon Wing
Belmont Grove
LS2 9NS
Recruitment starts
Recruitment ends
Local site investigator
Tim Lee
Trial Coordinators
Yasmin Khanagha
[email protected]
Closed

Liverpool - Alder Hey Children's Hospital

CTAP centre
NHS Trust
Alder Hey Children's NHS Foundation Trust
Address
Eaton Road
West Derby
L12 2AP
Recruitment starts
Recruitment ends
Local site investigator
Rebecca Thursfield
Trial Coordinators
Victoria King
[email protected]
Closed

Manchester Royal Infirmary

NHS Trust
Manchester University NHS Foundation Trust
Address
Oxford Road
M13 9WL
Recruitment ends
Closed

Nottingham City Hospital (Adults)

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Address
City Hospital, Wolfson Cystic Fibrosis Centre
Hucknall Road
NG5 1PB
Recruitment ends
Local site investigator
Helen Barr
Trial Coordinators
Fozia Naushahi
[email protected]
Closed

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Recruitment starts
Local site investigator
Jane Davies
Trial Coordinators
Sophie Pinnell
[email protected]
Closed

Royal Devon & Exeter Hospital

CTAP centre
NHS Trust
The Royal Devon & Exeter NHS Foundation Trust
Address
Barrack Road
EX2 5DW
Recruitment starts
Recruitment ends
Local site investigator
Nick Withers
Trial Coordinators
Sophie Whiteley
[email protected]
Closed

Southampton General Hospital

CTAP centre
NHS Trust
University Hospital Southampton NHS Foundation Trust
Address
Tremona Road
SO16 6YD
Recruitment starts
Recruitment ends
Local site investigator
Julian Legg
Trial Coordinators
Matthew Harvey
[email protected]
Closed

St Bartholomew's Hospital (London) - Adults

CTAP centre
NHS Trust
Barts Health NHS Trust
Address
West Smithfield
EC1A 7BE
Trial Coordinators
Sandra Pereira
[email protected]
Closed

St James's University Hospital - Leeds (Adults)

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
St James's University Hospital
Beckett Street
LS9 7TF
Recruitment ends
Trial Coordinators
Helen Chadwick
[email protected]
Closed

University Hospital Lewisham

NHS Trust
Lewisham and Greenwich NHS Trust
Address
Lewisham High Street
SE13 6LH